SCHWANN CELL CLINICAL TRIAL FOR CHRONIC SCI APPROVED BY THE FDA

The Miami Project to Cure Paralysis, at the University of Miami Miller School of Medicine has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase I clinical trial to evaluate the safety of autologous human Schwann cell transplantation in the chronic spinal cord injury (SCI) setting.

The clinical protocol of the Phase I trial is focused on safety and feasibility outcomes. The investigative team is already conducting a Phase I trial assessing safety of autologous Schwann cell transplantation in individuals with subacute SCI. The new trial will be conducted in parallel and focus on individuals with chronic SCI. Individuals that are at least 1 year post-injury will have to meet the inclusion/exclusion criteria and agree to participate in the trial, which initially will require approximately 10 months of their time.

Participants will be monitored long-term for a total of five years. Each participant’s own Schwann cells will be obtained from a sural nerve biopsy. The Schwann cells will then need to be derived from the nerve and processed in a culturing facility to generate the number of cells necessary for transplantation, and to undergo a purification process. The cell therapy will be combined with an intense exercise and rehabilitation intervention to maximize outcome.

Led by W. Dalton Dietrich, Ph.D., Scientific Director, The Miami Project to Cure Paralysis, the Schwann cell clinical trial team is comprised of a multi-disciplinary group of faculty level scientists, neurosurgeons, and staff focused on advancing the trial.

The Clinical Trials Initiative is The Miami Project’s efforts to carefully take new discoveries from the laboratory to test as treatments in clinical trials. With a special emphasis on spinal cord injury, the Clinical Trials Initiative was started in 2004 and is aimed at creating the infrastructure needed to gain approval for and to conduct clinical trials at the University of Miami affiliated hospitals. Two treatments we are currently testing under this clinical trials initiative are Schwann cell transplantation and therapeutic hypothermia. We anticipate these activities will bring new and potentially life-changing treatments to people with central nervous system trauma.

Scientific Research

Our broad scope of collaborative research is dedicated to finding new treatments for spinal cord injury.

DIGNITARIES GATHER FOR THE GROUNDBREAKING CEREMONY OF THE CHRISTINE E. LYNN REHABILITATION BUILDING FOR THE MIAMI PROJECT TO CURE PARALYSIS

April 2015 - Nick and Marc Buoniconti, University of Miami President Donna E. Shalala, Jackson Health System President and CEO Carlos A. Migoya, and other dignitaries gathered today to celebrate the groundbreaking of the Christine E. Lynn Rehabilitation Center for The Miami Project to Cure Paralysis at University of Miami/Jackson Memorial Medical Center.

ASH'S ADVICE

March 18th of this year marked the seventeen year anniversary of the automobile accident that left me paralyzed from the neck down. Seventeen years is quite a long time and I believe by now I have living with a spinal cord injury down to a science. Sure, I have my days of not knowing exactly how to live life as a quadriplegic, but overall I have been quite blessed with maintaining a healthy lifestyle in my condition.